Validation of a Diagnostic Test for Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Anti-coagulated Blood

PATH

Status: Completed

Conditions: G6PD Deficiency

Treatments: Diagnostic Test: HemoCue System; Diagnostic Test: Pointe Scientific Test Kit; Diagnostic Test: SD Biosensor STANDARD G6PD Test

Study type: Interventional

Funder types: Other

Identifiers

NCT04054661

1416844

Details and patient eligibility

About

The primary objective of the study is to assess the accuracy of the SD Biosensor STANDARD™ point-of-care (POC) G6PD test in measuring G6PD activity and classifying results compared to a reference assay and across repeated measurements in capillary samples.

Full description

Cross-sectional diagnostic accuracy study with 250 volunteer participants. The clinic will recruit and consent adult study participants. Clinic staff will draw venous blood and obtain finger stick capillary blood samples. Clinic staff will perform the investigational SD Biosensor STANDARD™ G6PD test for glucose-6-phosphate dehydrogenase (G6PD) deficiency and a HemoCue® hemoglobin test on finger stick capillary blood. An anti-coagulated venous blood sample will be sent to a Clinical Laboratory Improvement Amendments (CLIA) certified lab for G6PD reference testing by the gold standard assays: G6PD measurement by spectrophotometry using the Pointe Scientific G6PD reference assay and hemoglobin measurement by a hematology analyzer.

Individuals identified as G6PD deficient or intermediate by the reference test will be notified of their results by the clinic and referred to their physician for follow-up.

This study includes a nested repeatability study and a nested sample stability study. In the nested repeatability study up to 20 consented participants will provide 4 additional finger stick samples. Clinic staff will perform the SD Biosensor STANDARD™ G6PD test to assess the repeatability of the test in capillary blood over 8 G6PD and hemoglobin measurements on up to 3 different instruments.

In the nested sample stability study up to 8 consented participants will provide an additional venous blood draw sample to be tested at additional time points to document stability of the samples over time when tested by the SD Biosensor STANDARD™ G6PD Test.

Enrollment: 229 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must communicate an understanding of the study protocol.
• Must be able to provide written consent to undergo screening and provide medical history.
• Participants must be afebrile and in general good health in the opinion of the investigator as determined by vital signs, medical history, and physical examination.
• Black/African-American, by self-report.

Exclusion criteria

• Blood transfusion in the past 3 months by self-report

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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229 participants in 1 patient group

G6PD Diagnostic Testing

Other group

Description:

Participants provided whole blood samples as well as fingerstick capillary blood samples. At the clinic site lab, study staff conducted the SD Biosensor STANDARD point-of-care G6PD test and the point-of-care HemoCue hemoglobin test on both finger stick blood and whole blood samples. At the reference laboratory, G6PD activity was measured from whole blood samples using the Pointe Scientific G6PD reference assay and hemoglobin was measured using a hematology analyzer.

Treatment:

Diagnostic Test: SD Biosensor STANDARD G6PD Test

Diagnostic Test: Pointe Scientific Test Kit

Diagnostic Test: HemoCue System